(308 days)
Not Found
No
The summary describes a physical face mask with features for seal and comfort, and explicitly states "Not Found" for mentions of AI, DNN, or ML, and lacks descriptions of training or test sets typically associated with AI/ML devices.
Yes
This device is used for the treatment of OSA and/or ventilatory support, which directly addresses a medical condition.
No
This device is a patient interface (face mask) for delivering CPAP and bi-level ventilation for the treatment of OSA or ventilatory support. It is a therapy delivery device, not a device used to identify, detect, or monitor a medical condition.
No
The device description clearly describes a physical face mask with adhesive foam and an exhalation port, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The described device is a patient interface face mask used with CPAP and bi-level systems for treating sleep apnea and providing ventilatory support. Its function is to deliver air to the patient's airway, not to analyze biological samples.
- Intended Use: The intended use clearly states its purpose is for treatment and ventilatory support, not for diagnostic testing.
- Device Description: The description focuses on features related to sealing, comfort, and positioning on the face, which are relevant to delivering air, not performing diagnostic tests.
- Lack of IVD Indicators: There is no mention of analyzing samples, chemical reactions, or any other processes typically associated with IVD devices.
Therefore, this device falls under the category of a respiratory support device or patient interface, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
A patient interface, face mask, for use with CPAP and bi-level systems used in the treatment of adult (>30 kg) OSA and / or ventilatory support. Two styles (with exhalation port and without exhalation port). Single use only 30 kg)
Intended User / Care Setting
Hospitals, Home, sub-acute care settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).
0
K071915 Page 1 of 3
MAY 1 4 2008
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 3 7-May-08
| ARCimed Laboratories, LLC
85 Oak Street
| Weston, MA 02493 | Tel - 781-237-4544 |
|---|---|
| Official Contact: | Robert W. Daly, Managing Member |
| Proprietary or Trade Name: | ARCimed CPAP mask |
| Common/Usual Name: | Patient interface for use with CPAP systems |
| Classification Name: | Ventilator, non-continuous (respirator), accessory |
| BZD - 868.5905 | |
| Device: | ARCimed CPAP mask |
| Predicate Devices: | ResMed - Quattro Full Face Mask - K063122 |
| Advanced Warming - Adhesive mask - K950771 | |
| Respironics Full face mask - K002465 |
Device Description:
The proposed patient interface face mask incorporates a number of features, which are designed to maximize seal and comfort, and maintain the mask in the correct position throughout use.
- Adhesive foam to seal to the patient face .
- . One size - medium
- Models with and without Integral fixed leak (exhalation) port .
| Indications for Use: | A patient interface, face mask, for use with CPAP and bi-level systems used in the treatment of adult (>30 kg) OSA and / or ventilatory support. Two styles (with exhalation port and without exhalation port). | |
|---|---|---|
| Single use only 30 kg) with OSA | ||
| Environment of Use: | Hospitals, Home, sub-acute care settings |
1
K071915 Page 2 of 3
Non-Confidential Summary of Safety and Effectiveness
Comparative table:
| Features | Predicates | Proposed Device |
|---|---|---|
| ResMed Quattro | ||
| Full Face Mask - K063122 | ||
| Advanced Warming - | ||
| Adhesive Mask - K950771 | ||
| Respironics Full face mask – | ||
| K002465 | ARCimed CPAP mask | |
| Indications for use | A patient interface for use with | |
| CPAP and bi-level systems used | ||
| in the treatment of adult (> 30 | ||
| kg) OSA and / or ventilatory | ||
| support. |
Anesthesia face mask with
adhesive seal (Advanced
Warming - K950771) | A patient interface for use with
CPAP and bi-level systems used in
the treatment of adult (>30 kg) OSA
and / or ventilatory support. |
| Environment of
Use | Home, Hospital, Sub-acute
Institutions | Same |
| Patient Population | Adult | Same |
| Contraindications | None | None |
| Disposable, single
patient use | No – multi-use – K063122
Yes – K950771 | Yes |
| Components | Shell
Cushion
Adhesive seal (K950771) | Shell
Foam
Adhesive seal |
| Dead space | 203 ml (K063122) | 91 ml |
| Fixed leak port | ResMed Quattro K063122 | |
| Exhaust Flow
range | Pressure / Flow (lpm)
3 cm H2O / 17.8 lpm
10 cm H2O / 31.5 lpm
20 cm H2O / 42.6 lpm
30 cm H2O / 51.7 lpm
40 cm H2O / 60.1 lpm | Pressure / Flow (lpm)
3 cm H2O / 19.9 lpm
10 cm H2O / 33.3 lpm
20 cm H2O / 47.1 lpm
30 cm H2O / 58.0 lpm
40 cm H2O / 67.8 lpm
Pass / fail +/- 15% |
2
K071915 Page 3 of 3
Non-Confidential Summary of Safety and Effectiveness Page 3 of 3 7-May-08
| Features | Predicates | Proposed Device |
|---|---|---|
| ResMed Quattro | ||
| Full Face Mask - K063122 | ||
| Advanced Warming – | ||
| Adhesive Mask - K950771 | ||
| Respironics Full face mask – | ||
| K002465 | ARCimed CPAP mask | |
| Vented and | ||
| Non-vented styles | ||
| requires anti- | ||
| asphyxia valve in | ||
| the circuit | Yes – ResMed – K063122 |
Offer a mask with optional anti-asphyxia valve | Vented and Non-vented models
requires attachment to a circuit with
anti-asphyxia valve incorporated
demonstrated to activate AAV valve
equivalent to predicates
Should be used with AAV with
minimum opening pressures of 30 kg) OSA and / or ventilatory support. Two styles (with exhalation port and without exhalation port).
Single use only